Double-Blind

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Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer. PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

Background information
Trial ID: 
NCT00729287
Other unique IDs: 
CDR0000602239
UZG-CUL-UHG-Non-Invasive Bladd
EU-20870
Official title: 

Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-Invasive Bladder Cancer

Detailed description: 

OBJECTIVES: Primary

  • To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.

Secondary

  • To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.

Number to be enrolled: 
900 patients

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.

Background information
Trial ID: 
NCT00728585
Other unique IDs: 
CDR0000588622
COG-ACCL0521
Official title: 

A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description: 

OBJECTIVES: Primary

  • To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.

Number to be enrolled: 
200 patients

PPhase II Study on Patients With Acute Exacerbation of Schizophrenia

Phase II study in patients with acute exacerbation of schizophrenia. The primary objective is to evaluate the efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks' treatment in patients with schizophrenia

Background information
Other unique IDs: 
CR014737

A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Background information
Trial ID: 
NCT00727987
Other unique IDs: 
CR015340
Official title: 

A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis

Detailed description: 

This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152.

Number to be enrolled: 
240 patients

Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)

Trial phase: 
Phase IV
Recruitment status: 
Completed

Lateral episiotomy is a current care practiced with childbirth room. One of the problems encountered with this surgical act is the residual pain on perineal scar level. Maximal during the first 24 hours, this pain can persist several days or several weeks hampering to variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown the interest of ropivacaine, local anaesthetic with a long action's duration for proctologic surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of cases and a first analgesics request delayed to ten hours. Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled. The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine 0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed during the 24 first hours. This study was designed as double blind and the study conduct was standardized in order to get only variable such as the episiotomy infiltration.

Background information
Trial ID: 
NCT00727935
Other unique IDs: 
CHU P 2006-03
Official title: 

Comparison Of The Analgesia Obtained By Infiltration Of Lidocaïne 1% And Ropivacaïne 0,75% Versus Placebo For The Joinings Of Episiotomies Among Parturients Under Epidural Analgesia

Detailed description: 

 

Number to be enrolled: 
165 patients
Acronym: 
LiRoPep

A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.

Trial phase: 
Phase IV
Recruitment status: 
Completed

The purpose of this study was to evaluate by histology and histomorphometry, thirty human osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of implantation. This study is part of a splitting-blind clinical investigation to compare the performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of wisdom teeth. The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson & Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer Bio-Gide®-membrane. This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation. This study was conducted in accordance with the requirements of the FDA (Department of health and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.

  • Trial with medical device

Background information
Trial ID: 
NCT00727818
Other unique IDs: 
R304 - 002
Official title: 

 

Detailed description: 

 

Number to be enrolled: 
0 patients

Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Trial phase: 
Phase III
Recruitment status: 
Completed

The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.

Background information
Trial ID: 
NCT00727129
Other unique IDs: 
P04-001
Official title: 

Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients

Detailed description: 

 

Number to be enrolled: 
495 patients

Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Recruitment status: 
Recruiting

Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. We have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. We propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Background information
Trial ID: 
NCT00725322
Other unique IDs: 
SU-01072008-965
11830
Official title: 

Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Detailed description: 

Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice we have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A. Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner.

Number to be enrolled: 
33 patients

Treatment of Schizoaffective Disorder Using Mifepristone

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

Background information
Trial ID: 
NCT00725270
Other unique IDs: 
SU-06012008-1191
76458
Official title: 

Treatment of Schizoaffective Disorder Using Mifepristone

Detailed description: 

You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown.

Number to be enrolled: 
30 patients

A Verification Study of CNTO 1275 in Patients With Plaque Psoriasis

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at weeks 0 and 4 and then every 12 weeks, using placebo as a control.

Background information
Trial ID: 
NCT00723528
Other unique IDs: 
CR015166
JNS009-JPN-02
Official title: 

A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis

Detailed description: 

This is a multicenter, randomized (patients assigned study drug by chance), double-blind (neither the patient nor the physician knows the assigned medication name), placebo-controlled, parallel-group comparison study. This study has been planned to examine the effectiveness and safety of CNTO 1275 in Japanese patients with moderate to severe plaque type psoriasis in subcutaneous administration of the drug using placebo as a control.

Number to be enrolled: 
150 patients
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